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Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome

Key facts

Who runs it
Boston University Charles River Campus
Where
Boston, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
60 people, planned
Starts
Jan 2027
Expected to end
Jan 2030
Type of study
Interventional
Treatments tested
  • PUMA
Record updated
13 November 2026

Who can take part

Age
6 months to 24 months
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Infants/toddlers inclusion criteria
  • confirmed diagnosis of Down syndrome
  • able to sit without support and not yet taking any independent steps; Primary caregiver inclusion criteria
  • proficient in English
  • has access to a computer, tablet or mobile phone with a camera and microphone
  • has access to zoom; Infants/toddlers exclusion criteria:
  • severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)

Where in United States

  • Charles River Campus, Boston UniversityBoston, United StatesContact: Jana M Iverson, PhDNot yet recruiting

About the trial

What the trial wants to find out

Infants with Down syndrome (DS) exhibit early developmental delays in motor skills and multiple other domains. Once infants are upright and moving, they have new opportunities for exploring the environment and interacting with objects and people that are important for early learning and development. This project will allow the investigators to assess the feasibility of a home-based mobility and play intervention for infants with DS (using a body weight supported harness system- Portable Mobility Use Aid (PUMA) for Children and characterize its impact on promoting mobility, exploration, and play with objects and caregivers. PUMA is a specialized pediatric partial body-weight support system designed to give children with developmental delays or physical disabilities the upright support they need to move, explore, and play independently.

The group in the trial

  • Portable Mobility Use Aid (PUMA) system for Children playtimeTreatment being tested

    The investigators will deliver a Portable Mobility Use Aid (PUMA) system for Children playtime to the home and assist caregivers with setup.

    Treatment: PUMA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Harnessing Opportunities for Mobility and Exploration (HOME): Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome
Record updated
13 November 2026